Kornimate/medical-research-clean huggingface dataset:
comparison of the safety and cost of a simplified post-operative radiograph (spor) protocol

Conditions: Fractures, Bone; Fracture Complications; Xray Complication

Summary: the standard post-operative radiographic protocol for the monitoring of fractures at health sciences centre includes post-operative in hospital radiographs as well as radiographs at the two week follow up appointment. this is in addition to good quality intra-operative radiographs. with current operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal fixation. in fact, patients are often allowed to take weight through the fractured limb immediately post-operatively. in these cases, redundant post-operative radiographs likely represent an avoidable cost to the system financially, and an avoidable cost to the patient in additional time spent in hospital and unnecessary radiation exposure.


Eligibility criteria:
inclusion criteria: * at least one lag screw for each fracture line * at least one compression plate across each fracture line * locked intramedullary nail * articular/peri-articular fracture with antiglide/under-contoured plate * tension band technique (plate included) in simple fracture pattern * operating surgeon is confident in fixation construct, despite non-load sharing criteria. exclusion criteria: * fracture \>21 days old * age \<18 years, or open growth plates * articular fracture with depression * multiple orthopaedic fractures * history or radiographic appearance of osteoporosis/osteopenia or poor operative bone quality * likely difficulty with follow-up in first 6 weeks
sleep quality in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study was designed to investigate the factors affecting sleep quality of rheumatoid arthritis patients in turkish population.

demographic data, duration of disease, routine biochemical tests and currently used medications were recorded. disease activity was assessed with disease activity score 28 (das 28). visual analog scale (vas) was used to evaluate pain levels. health assessment questionnaire (haq) was used to assess activities of daily living. beck depression inventory (bdi) was used to investigate the signs of depression in patients. sleep quality was considered to be poor in patients with a pittsburgh sleep quality index (psqi) global score of 5 and greater.

Eligibility criteria:
inclusion criteria: * patients with ra who met the 2010 american college of rheumatology (acr) ra classification criteria were included exclusion criteria: * patients who had difficulties understanding and responding to questions were excluded from the study.

Keywords: sleeping disorders sleep quality
bright light therapy for weight loss

Conditions: Obesity

Summary: the study investigates whether bright artificial light adds to hypocaloric diet to lose weight in obese subjects.

the study is aimed to check a preliminary evidence that bright light may help to lose weight in obese people (thor helge bergan, norvay, 2002, unpublished). subjects: aged 20-65 y, bmi \> 30, non-seasonal (spaq score \<8, no seasonal problem), in good general health, with regular sleep from 22:00-1:00 to 6:00-9:00. study season: november-april. placebo-controlled, single-blind, crossover. at least 1 mo between two arms; at similar phase of menstrual cycle (if present). if could not complete at the first year, the second arm is to be done the next winter. intervention: lightbox (4300 lux) - during one arm, deactivated ioniser - during another arm (sequential alternation upon entering the study) for 3 weeks each morning (at least 18 days) starting between 6:00-9:00. seating distance (from the face to the device) is 41 cm, duration - 30 min. diet: a target amount of kcal per day is calculated based on age, weight and gender (who), e.g. for a woman 40 y ang 80 kg it is 1502 kcal per day. food content - is also as recommended by who. food distribution over day - usual for the particular test subject but constant over sessions. food diary is completed daily and subjects calculate kcal themselves based on a table of kcal. outcomes: weight is measured during a visit to doctor a day before and day after the 3-week session, and also at home every week. motivation and expectation are rated by 3-point scales in a diary, at the beginning of each session. mood, activity and appetite are self-estimated using a vas-like 10-points scale every week. at the end of each arm the "easiness of dieting" scale and adverse event(s) are completed. in the diary, there are also columns for sleep on and off times, intervention time, duration and distance, number of kcal. a target number of subjects to complete the study is 40.

Eligibility criteria:
inclusion criteria: * age 20-65 y * bmi \> 30 * non-seasonal (spaq score \<8, no seasonal problem) * good general health; if there is a serious chronic disease - then compensated, with a constant dose of medication(s) * regular sleep from 22:00-1:00 to 6:00-9:00 * a wish to participate and complete the study exclusion criteria: * any acute disease during the past month * transmeridian travel \>3 time zones over the past month * a use of medication(s) which influence body weight - during the last 2 months

Keywords: obesity light therapy hypocaloric diet
pneumatic compression stockings during hemodialysis

Conditions: Hemodialysis

Summary: this study aims to determine the effect of pneumatic compression devices (pcds) on central blood volume in hemodialysis patients. we hypothesize that pcds will help maintain central blood volume, and therefore prevent sudden decreases in blood pressure during hemodialysis.


Eligibility criteria:
inclusion criteria: * on hemodialysis at least 3 months * on hemodialysis at least 3 times per week exclusion criteria: * dialyzing with a central venous catheter * vascular access dysfunction * peripheral vascular disease * active medical issue * unable to provide informed consent

Keywords: hemodialysis intradialytic hypotension
infusion of autologous t regulatory cells (t reg) at the time of transplantation of allogenic islets of langerhans

Conditions: Type1diabetes

Summary: open single armed study to investigate safety and feasibility of administrating autologous t regulatory cells at the time of allogenic islet transplantation.

open single armed study to investigate safety and feasibility of administrating autologous t regulatory cells at the time of allogenic islet transplantation. patients are recruited from the waiting list for islet transplantation within the nordic network for clinical islet transplantation. patients included in the study will undergo apheresis while on the waiting list. t regulatory cells will be sorted out and frozen. autologous, non modified t regs will then be infused simultaneously intraportally with the islet graft at transplantation. patients will be followed for safety and efficacy regarding the islet transplantation over three months

Eligibility criteria:
inclusion criteria: * patient must be registered on the waiting list within the nordic network for clinical islet transplantation * type 1 diabetes with diagnosed \ 5 years of exogenous insulin use * c peptide \< 0.1 nmol/l at mmtt if no previous islet transplant * adequate previous treatment by an experienced diabetologist * patient must understand and be able to sign an informed consent exclusion criteria: * patient with a previous transplant other than islets * patient with an bmi\>30 * patient with an need of more than 1u/kg of insulin per 24h * repeated abnormal liver function tests * non stable retinopathy * known abnormalities in coagulation * known malignancies * non stable heart conditions * active infections * serological proof of hepatitis b or c or hiv * signs of portal hypertension * patients that are pregnant, breast feeding or aim to become pregnant during the study period * patients with a pra \> 20%, positive cross match or known dsa * patients with conditions that the investigator would consider unsafe to combine with islet transplantation

Keywords: transplantation islets of langerhans t regulatory cells (autologous)
metronomic oral vinorelbine in patients with metastatic tumors

Conditions: Breast Cancer; Non Small Cell Lung Cancer; Prostate Cancer

Summary: patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of three different doses (30 or 40 or 50 mg). vinorelbine will be administered orally at a metronomic schedule three times a week: on monday, wednesday and friday.

the purpose of this study is to define the biologically optimal dose of vinorelbine when administered at a metronomic dosing schema. \[metronomic chemotherapy refers to the close, regular administration of minimally toxic doses of cytotoxic drugs, with minimal or no drug-free breaks, over prolonged periods\]. patients with recurrent or metastatic solid tumors are randomly assigned one of three different doses of oral vinorelbine (30 or 40 or 50 mg). treatment is administered three times a week (monday, wednesday and friday) continuously until disease progression or unacceptable toxicity or to a maximum of 24 months.

Eligibility criteria:
inclusion criteria: * signed informed consent * ages 16 - 75 years * genders: both * performance status 0-2 according to the world health organization (who) scale * life expectancy of at least 16 weeks * adequate bone marrow, hepatic and renal functions * absence of brain metastasis * metastatic/locally advanced refractory prostate, breast or non-small cell lung cancer previously treated with no more than two chemotherapeutic regimens * white blood cells \>= 3500/mm\^3 * absolute neutrophil count \>= 1500/mm\^3 * platelets \>= 100,000/mm\^3 * total serum bilirubin less than 1.5 mg/dl * serum transaminases less than 2.0 x upper normal limit (unl) unless attributed to liver metastases * serum creatinine within normal range exclusion criteria: * major active infection * more than two prior chemotherapy regimens for metastatic disease * any of the following within the 12 months prior to starting the study treatment: * myocardial infarction, * severe/unstable angina, * coronary/peripheral artery bypass graft, * congestive heart failure, * cerebrovascular accident or transient ischemic attack, or pulmonary embolism, * cardiac dysrhythmias of grade \>/= 2, * atrial fibrillation of any grade, or * heart rate corrected interval (qtc) \> 450 msec for males or \> 470 msec for females. * hypertension that cannot be controlled with medications (\> 150/100 mmhg despite optimal medical therapy) * ongoing anti-coagulation therapy * pregnancy or breastfeeding * other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration; or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.

Keywords: metronomic-therapy vinorelbine recurrent breast cancer recurrent non small cell lung cancer metastatic prostate cancer
endermotherapy for children with developmental disabilities

Conditions: Cerebral Palsy; Developmental Delay

Summary: children with developmental disabilities often sustain decreased range of motion in their extremities. the decrease in flexibility may be due to neuromuscular disorders such as spasticity or dystonia. other causes may be imbalance in muscle strength surrounding a joint, leading to inappropriate habitual posture. over time, muscle contracture may result for those muscle groups that are placed in a shortened position for an extended period of time. the most common site of muscle contractures among these children are gastrocnemius/soleus (lower limbs), and latissimus dorsi muscles (upper limbs). muscle contractures can lead to further decline in functional abilities. therefore, it is important to identify effective intervention strategies to enhance or maintain muscle flexibility in children with developmental dysfunctions. commercially available endermotherapy device has been used to soften scar tissue following burn injuries. the mechanical stimulation applied may also have beneficial effects on relaxing the muscle tissue. the overall aim of the proposed study is to determine whether endermotherapy treatment has immediate effect in improving joint range of motion among children with developmental disabilities. the research hypothesis is that children in the endermotherapy group will have significantly more gain in ankle passive range of motion than those in the control group.


Eligibility criteria:
inclusion criteria: * children aged between 2 and 6. * children with diagnosis of cerebral palsy or developmental disabilities. * has limited ankle dorsiflexion range of motion (less than 20 degrees) exclusion criteria: * other serious illnesses that preclude participation

Keywords: flexibility muscle stretching cerebral palsy developmental
a study of rnk05047 in subjects with advanced solid tumors/diffuse large b-cell lymphoma (champ-1)

Conditions: Advanced Solid Tumor; DLBCL

Summary: this is a first in human, phase 1/2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability, pk, pd and efficacy of rnk05047 when administered an intravenous (iv) infusion to subjects with advanced solid tumors, including diffuse large b-cell lymphoma (dlbcl). this is a 2-part study (dose escalation, cohort expansion) with sequential enrollment.

in part 1, enrolled subjects will receive iv rnk05047 once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week). the dose-escalation phase will follow a standard 3+3 design, with 3 subjects enrolled into the first dosing cohort to receive rnk05047 at the starting dose of 0.75 mg/kg. in part 2, once rp2d has been established, additional subjects (3 to 5 cohorts of approximately 15 subjects per cohort) will be enrolled in the cohort-expansion phase of the study. tumor types for these cohorts will be determined based on data from the dose-escalation phase of the study and emerging results from preclinical studies or other scientific data. these dose expansion cohorts in all groups may be done concurrently.

Eligibility criteria:
inclusion criteria: * pathologically documented locally advanced or metastatic solid tumor * refractory or intolerant to all available standard-of-care therapies for advanced disease * measurable disease * archived tumor tissue collected * ecog performance status of 0 or 1 * bmi ≥ 18 kg/m2 * adequate liver, renal, hematologic, and coagulation parameters * negative serum pregnancy test (for women of childbearing potential) at screening and a negative urine or serum pregnancy test on day 1 prior to the first infusion * males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 4 months after the last dose of study treatment. * must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent. exclusion criteria: * concurrent anticancer therapy: radiotherapy, chemotherapy, biological therapy, or other anticancer investigational agents note: at least 5 half-lives must have been ensued for any prior systemic cancer therapy agent before subject received the study drug on day 1 * unresolved toxicities from prior anticancer therapy, defined as not having resolved according to ctcae version 5.0 grade ≤ 1, excluding grade 1 alopecia * presence or suspicion of active central nervous system (cns) metastases and/or leptomeningeal carcinomatosis * peripheral neurotoxicity ≥ grade 2 according to ctcae v5.0 * known active infection with hiv, htlv-1, hepatitis b or c * women who are pregnant or breastfeeding * history of another malignancy unless the subject has been treated with curative intent for this malignancy

Keywords: protein degrader
ethyl chloride versus 5% lidocaine for topical anesthesia of oral mucosa

Conditions: Pain; Symptomatic Irreversible Pulpitis

Summary: local anesthesia in the oral cavity is a pain full experience for the patient. all means should be made to reduce the pain and anxiety of the patient for needle stick procedures. my study aims in elevating the pain experienced by the patient during this procedure by using either cold application with ethyl chloride or 5% lidocaine gel.

local anesthetic procedure is always a dreadful experience for the patient specially for the patients who are already in pain . it is a job of the dentist to provide a painless dental treatment from the very beginning. most dental procedures require administration of local anesthesia for a painless procedure with local anesthesia procedure being painful itself with the administration of needle in the oral cavity. dentist everyday in their practice utilise various techniques and procedures in alleviating this painful experience with either application of lidocaine gel or spray . numbing the oral mucosa with cold application is well documented and tested therefore my study aims in application of ethyl chloride spray on cotton pallet for a duration of 30 seconds in producing the desired numbing effect of the oral mucosa before infiltration of local anesthesia in alleviating the needle prick sensation perceived by the patient. pain level is assigned to one of four categorical scores using visual analogue scale 1. :none(0) 2. : mild (1-3) 3. : moderate (4-6) 4. : severe (7-10)

Eligibility criteria:
inclusion criteria: * no medical history * no age restrictions * patients suffering from symptomatic irreversible pulpitis requiring buccal infiltration exclusion criteria: * patients having any medical conditions considered to affect patient safety or the quality of the study * if they had any known hypersensitivity to local anaesthetics of amide type or any of the other contents in the substance used
impact of a self-hypnosis practice on chronic stress among caregivers of elderly people with loss of autonomy at home

Conditions: Stress

Summary: in france, stress particularly affects family caregivers because of the intensive help they provide on a permanent basis to people losing their autonomy at home. this care work is often considered as a "burden" and has all the characteristics of a chronic daily stress factor. the prevalence of stress among caregivers is high and the level of stress varies according to the type of care provided to seniors at home. this chronic stress has harmful effects on the health of family caregivers (depression, fatigue, insomnia, onset of chronic diseases, early mortality). it can be detrimental to their well-being and quality of life. however, ageing well at home for older people is based on this essential pillar: the caregivers. they must remain in good physical and psychological health. reducing their daily stress is becoming a public health challenge and a national priority. currently, the management of caregiver stress is based on several measures and devices. non-conventional care practices such as mindfulness-based stress reduction, meditation, relaxation and yoga are offered to family caregivers. initial results of studies on the effect of these complementary medicines show an improvement in psychological stress. however, research in this field is relatively recent. the conclusions must therefore be approached with caution. moreover, no medium or long-term evaluation has been found in the scientific literature. self-hypnosis is becoming a common practice in healthcare. it has demonstrated its effectiveness in reducing pain and anxiety in both adults and children. in addition, other recent scientific evidence supports the effectiveness of hypnosis in stress management. in france, no study on caregiver stress and its management by self-hypnosis has been identified in the literature. the hypothesis is that the stress level of caregivers of elderly people at home could be reduced through daily self-hypnosis practice at home.


Eligibility criteria:
inclusion criteria: * stress \> or = 3 evaluated by the analogic visual scale of chamoux * caregiver at home for a person uper than 60 years old with a loss of autonomy and followed in geriatrics or in polyvalent medicine * daily help in at least one of the 3 spheres of the elderly activity * person providing care services for more than 2 years with the elderly * person who can read and write * person affiliated to a social security scheme * person who gives his oral express consent * person who lives in reunion island exclusion criteria: * person with serious chronic disorder (cancer for example) * person with a contraindication to hypnosis (cognitive and psychiatric disorders or alcohol dependence) * person under specific treatment preventing them from performing the intervention consistently * person who has already practiced hypnosis

Keywords: family caregivers aged persons homebound persons chronic stress self-hypnosis
personalized tidal volume in ards (vt4hemod)

Conditions: Acute Respiratory Distress Syndrome

Summary: treatment of acute respiratory distress syndrome (ards) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). mortality of ards remains high in observational studies (40 to 50%). approximately 30% of ards patients exhibit tidal hyperinflation despite low tidal volume ventilation, suggesting that personalization of tidal volume is required to improve ards prognostic. to date, reliable bedside tools to adjust tidal volume are lacking. excessive tidal volume can be detected using computed tomography by quantification of tidal hyperinflation, but this technique is reserved to research studies and requires patient transport to imaging facility. mechanical ventilation generates cardio-pulmonary interaction, whose magnitude is influenced by tidal volume and respiratory system characteristics. pulse pressure variation is a bedside tool with potential to quantify cardio-pulmonary interactions. increasing tidal volume will decrease right ventricular preload and increase right ventricular afterload, hence maximizing cardio-pulmonary interactions. the investigators hypothesize that pulse pressure variation might help to detect excessive tidal volume during a tidal volume challenge (i.e. stepwise increase in tidal volume)


Eligibility criteria:
inclusion criteria: 1. age greater then 18 years old 2. ards according to the berlin definition with pao2/fio2 ratio ≤ 150 mm hg 3. invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight 4. use of sedation and neuromuscular-blocking agents 5. arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution 6. central venous catheter implanted in the superior vena cava territory 7. esophageal balloon 8. computed tomography planned by attending physician exclusion criteria: 1. previous inclusion in current study 2. acute cor pulmonale 3. ecmo 4. arterial ph \< 7.21 despite respiratory rate set to a maximum of 35/min 5. pneumothorax or bronchopleural fistula 6. decision to withdraw or withhold life sustaining treatment with 24 hours from inclusion 7. contra-indication of transport to imaging facility 8. intracranial hypertension 9. tricuspid or pulmonary mechanical valve 10. tricuspid or pulmonary infective endocarditis 11. pace maker with intracardiac leads 12. right ventricle tumor 13. complete left bundle block 14. intrathoracic metallic device 15. copd 16. cardiac arrythmia 17. vesical pressure \> 15 mm hg 18. lower limb amputation 19. inferior vena cava thrombosis 20. patient under an exclusion period relative to participation to another clinical trial 21. patient under a legal protective measure 22. patient not affiliated to social security 23. lac of patient/representative consent 24. pregnancy 25. breast feeding

Keywords: acute respiratory distress syndrome cardiopulmonary interaction tidal volume computed tomography